Mask sizing tool using a mobile application

ABSTRACT

Apparatus and methods automate selection of patient interface(s) according to their size, such as with processing in a processor(s) or in a server(s). Image data captured by an image sensor may be received. The captured image data may contain facial feature(s) of an intended user of the patient interface. The facial features may be captured in association with a predetermined reference feature of known dimension(s). The user&#39;s facial feature(s) and the reference feature may be detected in the captured image data. Image pixel data of the image may be processed to measure an aspect of the detected facial feature(s) based on the reference feature. A patient interface size may be detected from standard patient interface sizes based on a comparison between the measured aspect of the facial feature(s) and a data record relating sizing information of the standard patient interface sizes and the measured aspect of the facial feature(s).

1 CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/578,440, filed Nov. 30, 2017, which is a national phase entry under35 U.S.C. § 371 of International Application No. PCT/AU2016/050560,filed Jun. 30, 2016, published in English, which claims priority fromU.S. Provisional Patent Application Nos. 62/313,202, filed Mar. 25, 2016and 62/186,461, filed Jun. 30 2015, all of which are incorporated hereinby reference.

2 STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

3 THE NAMES OF PARTIES TO A JOINT RESEARCH DEVELOPMENT

Not Applicable

4 SEQUENCE LISTING

Not Applicable

5 BACKGROUND OF THE TECHNOLOGY 5.1 Field of the Technology

The present technology relates to one or more of the detection,diagnosis, treatment, prevention and amelioration of respiratory-relateddisorders. The present technology also relates to medical devices orapparatus, and their use.

5.2 Description of the Related Art 5.2.1 Human Respiratory System andits Disorders

The respiratory system of the body facilitates gas exchange. The noseand mouth form the entrance to the airways of a patient.

The airways include a series of branching tubes, which become narrower,shorter and more numerous as they penetrate deeper into the lung. Theprime function of the lung is gas exchange, allowing oxygen to move fromthe air into the venous blood and carbon dioxide to move out. Thetrachea divides into right and left main bronchi, which further divideeventually into terminal bronchioles. The bronchi make up the conductingairways, and do not take part in gas exchange. Further divisions of theairways lead to the respiratory bronchioles, and eventually to thealveoli. The alveolated region of the lung is where the gas exchangetakes place, and is referred to as the respiratory zone. See“Respiratory Physiology”, by John B. West, Lippincott Williams &Wilkins, 9th edition published 2011.

A range of respiratory disorders exist. Certain disorders may becharacterised by particular events, e.g. apneas, hypopneas, andhyperpneas.

Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing(SDB), is characterized by events including occlusion or obstruction ofthe upper air passage during sleep. It results from a combination of anabnormally small upper airway and the normal loss of muscle tone in theregion of the tongue, soft palate and posterior oropharyngeal wallduring sleep. The condition causes the affected patient to stopbreathing for periods typically of 30 to 120 seconds in duration,sometimes 200 to 300 times per night. It often causes excessive daytimesomnolence, and it may cause cardiovascular disease and brain damage.The syndrome is a common disorder, particularly in middle agedoverweight males, although a person affected may have no awareness ofthe problem. See U.S. Pat. No. 4,944,310 (Sullivan).

Cheyne-Stokes Respiration (CSR) is another form of sleep disorderedbreathing. CSR is a disorder of a patient's respiratory controller inwhich there are rhythmic alternating periods of waxing and waningventilation known as CSR cycles. CSR is characterised by repetitivede-oxygenation and re-oxygenation of the arterial blood. It is possiblethat CSR is harmful because of the repetitive hypoxia. In some patientsCSR is associated with repetitive arousal from sleep, which causessevere sleep disruption, increased sympathetic activity, and increasedafterload. See U.S. Pat. No. 6,532,959 (Berthon-Jones).

Obesity Hyperventilation Syndrome (OHS) is defined as the combination ofsevere obesity and awake chronic hypercapnia, in the absence of otherknown causes for hypoventilation. Symptoms include dyspnea, morningheadache and excessive daytime sleepiness.

Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a groupof lower airway diseases that have certain characteristics in common.These include increased resistance to air movement, extended expiratoryphase of respiration, and loss of the normal elasticity of the lung.Examples of COPD are emphysema and chronic bronchitis. COPD is caused bychronic tobacco smoking (primary risk factor), occupational exposures,air pollution and genetic factors. Symptoms include: dyspnea onexertion, chronic cough and sputum production.

Neuromuscular Disease (NMD) is a broad term that encompasses manydiseases and ailments that impair the functioning of the muscles eitherdirectly via intrinsic muscle pathology, or indirectly via nervepathology. Some NMD patients are characterised by progressive muscularimpairment leading to loss of ambulation, being wheelchair-bound,swallowing difficulties, respiratory muscle weakness and, eventually,death from respiratory failure. Neuromuscular disorders can be dividedinto rapidly progressive and slowly progressive: (i) Rapidly progressivedisorders: Characterised by muscle impairment that worsens over monthsand results in death within a few years (e.g. Amyotrophic lateralsclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers);(ii) Variable or slowly progressive disorders: Characterised by muscleimpairment that worsens over years and only mildly reduces lifeexpectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic musculardystrophy). Symptoms of respiratory failure in NMD include: increasinggeneralised weakness, dysphagia, dyspnea on exertion and at rest,fatigue, sleepiness, morning headache, and difficulties withconcentration and mood changes.

Chest wall disorders are a group of thoracic deformities that result ininefficient coupling between the respiratory muscles and the thoraciccage. The disorders are usually characterised by a restrictive defectand share the potential of long term hypercapnic respiratory failure.Scoliosis and/or kyphoscoliosis may cause severe respiratory failure.Symptoms of respiratory failure include: dyspnea on exertion, peripheraloedema, orthopnea, repeated chest infections, morning headaches,fatigue, poor sleep quality and loss of appetite.

A range of therapies have been used to treat or ameliorate suchconditions. Furthermore, otherwise healthy individuals may takeadvantage of such therapies to prevent respiratory disorders fromarising.

5.2.2 Positive Pressure Therapies

Continuous Positive Airway Pressure (CPAP) therapy has been used totreat Obstructive Sleep Apnea (OSA). The hypothesis is that continuouspositive airway pressure acts as a pneumatic splint and may preventupper airway occlusion by pushing the soft palate and tongue forward andaway from the posterior oropharyngeal wall. Treatment of OSA by CPAPtherapy may be voluntary, and hence patients may elect not to complywith therapy if they find devices used to provide such therapy one ormore of: uncomfortable, difficult to use, expensive and aestheticallyunappealing.

Non-invasive ventilation (NIV) provides ventilatory support to a patientthrough the upper airways to assist the patient in taking a full breathand/or maintain adequate oxygen levels in the body by doing some or allof the work of breathing. The ventilatory support is provided via apatient interface. NIV has been used to treat CSR, OHS, COPD, MD andChest Wall disorders. In some forms, the comfort and effectiveness ofthese therapies may be improved.

Invasive ventilation (IV) provides ventilatory support to patients thatare no longer able to effectively breathe themselves and may be providedusing a tracheostomy tube. In some forms, the comfort and effectivenessof these therapies may be improved.

5.2.3 Diagnosis and Treatment Systems

These therapies may be provided by a treatment system or device. Systemsand devices may also be used to diagnose a condition without treatingit.

A treatment system may comprise a Respiratory Pressure Therapy Device(RPT device), an air circuit, a humidifier, a patient interface, anddata management.

Another form of treatment system is a mandibular repositioning device.

5.2.3.1 Patient Interface

A patient interface may be used to interface respiratory equipment toits wearer, for example by providing a flow of air to an entrance to theairways. The flow of air may be provided via a mask to the nose and/ormouth, a tube to the mouth or a tracheostomy tube to the trachea of apatient. Depending upon the therapy to be applied, the patient interfacemay form a seal, e.g., with a region of the patient's face, tofacilitate the delivery of gas at a pressure at sufficient variance withambient pressure to effect therapy, e.g., at a positive pressure ofabout 10 cmH₂O relative to ambient pressure. For other forms of therapy,such as the delivery of oxygen, the patient interface may not include aseal sufficient to facilitate delivery to the airways of a supply of gasat a positive pressure of about 10 cmH₂O.

The design of a patient interface presents a number of challenges. Theface has a complex three-dimensional shape. The size and shape of nosesvaries considerably between individuals. Since the head includes bone,cartilage and soft tissue, different regions of the face responddifferently to mechanical forces. The jaw or mandible may move relativeto other bones of the skull. The whole head may move during the courseof a period of respiratory therapy.

As a consequence of these challenges, some masks suffer from being oneor more of obtrusive, aesthetically undesirable, costly, poorly fitting,difficult to use, and uncomfortable especially when worn for longperiods of time or when a patient is unfamiliar with a system. Forexample, masks designed solely for aviators, masks designed as part ofpersonal protection equipment (e.g. filter masks), SCUBA masks, or forthe administration of anaesthetics may be tolerable for their originalapplication, but nevertheless such masks may be undesirablyuncomfortable to be worn for extended periods of time, e.g., severalhours. This discomfort may lead to a reduction in patient compliancewith therapy. This is even more so if the mask is to be worn duringsleep.

CPAP therapy is highly effective to treat certain respiratory disorders,provided patients comply with therapy. If a mask is uncomfortable, ordifficult to use a patient may not comply with therapy. Since it isoften recommended that a patient regularly wash their mask, if a mask isdifficult to clean (e.g., difficult to assemble or disassemble),patients may not clean their mask and this may impact on patientcompliance.

While a mask for other applications (e.g. aviators) may not be suitablefor use in treating sleep disordered breathing, a mask designed for usein treating sleep disordered breathing may be suitable for otherapplications.

For these reasons, patient interfaces for delivery of CPAP during sleepform a distinct field.

5.2.3.1.1 Seal-Forming Portion

Patient interfaces may include a seal-forming portion. Since it is indirect contact with the patient's face, the shape and configuration ofthe seal-forming portion can have a direct impact the effectiveness andcomfort of the patient interface.

A patient interface may be partly characterised according to the designintent of where the seal-forming portion is to engage with the face inuse. In one form of patient interface, a seal-forming portion maycomprise two sub-portions to engage with respective left and rightnares. In one form of patient interface, a seal-forming portion maycomprise a single element that surrounds both nares in use. Such singleelement may be designed to for example overlay an upper lip region and anasal bridge region of a face. In one form of patient interface aseal-forming portion may comprise an element that surrounds a mouthregion in use, e.g. by forming a seal on a lower lip region of a face.In one form of patient interface, a seal-forming portion may comprise asingle element that surrounds both nares and a mouth region in use.These different types of patient interfaces may be known by a variety ofnames by their manufacturer including nasal masks, full-face masks,nasal pillows, nasal puffs and oro-nasal masks.

A seal-forming portion that may be effective in one region of apatient's face may be inappropriate in another region, e.g. because ofthe different shape, structure, variability and sensitivity regions ofthe patient's face. For example, a seal on swimming goggles thatoverlays a patient's forehead may not be appropriate to use on apatient's nose.

Certain seal-forming portions may be designed for mass manufacture suchthat one design fit and be comfortable and effective for a wide range ofdifferent face shapes and sizes. To the extent to which there is amismatch between the shape of the patient's face, and the seal-formingportion of the mass-manufactured patient interface, one or both mustadapt in order for a seal to form.

One type of seal-forming portion extends around the periphery of thepatient interface, and is intended to seal against the patient's facewhen force is applied to the patient interface with the seal-formingportion in confronting engagement with the patient's face. Theseal-forming portion may include an air or fluid filled cushion, or amoulded or formed surface of a resilient seal element made of anelastomer such as a rubber. With this type of seal-forming portion, ifthe fit is not adequate, there will be gaps between the seal-formingportion and the face, and additional force will be required to force thepatient interface against the face in order to achieve a seal.

Another type of seal-forming portion incorporates a flap seal of thinmaterial positioned about the periphery of the mask so as to provide aself-sealing action against the face of the patient when positivepressure is applied within the mask. Like the previous style of sealforming portion, if the match between the face and the mask is not good,additional force may be required to achieve a seal, or the mask mayleak. Furthermore, if the shape of the seal-forming portion does notmatch that of the patient, it may crease or buckle in use, giving riseto leaks.

Another type of seal-forming portion may comprise a friction-fitelement, e.g. for insertion into a naris, however some patients findthese uncomfortable.

Another form of seal-forming portion may use adhesive to achieve a seal.Some patients may find it inconvenient to constantly apply and remove anadhesive to their face.

A range of patient interface seal-forming portion technologies aredisclosed in the following patent applications, assigned to ResMedLimited: WO 1998/004,310; WO 2006/074,513; WO 2010/135,785.

One form of nasal pillow is found in the Adam Circuit manufactured byPuritan Bennett. Another nasal pillow, or nasal puff is the subject ofU.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-BennettCorporation.

ResMed Limited has manufactured the following products that incorporatenasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask,SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGELIBERTY™ full-face mask. The following patent applications, assigned toResMed Limited, describe examples of nasal pillows masks: InternationalPatent Application WO 2004/073,778 (describing amongst other thingsaspects of the ResMed Limited SWIFT™ nasal pillows), US PatentApplication 2009/0044808 (describing amongst other things aspects of theResMed Limited SWIFT™ LT nasal pillows); International PatentApplications WO 2005/063,328 and WO 2006/130,903 (describing amongstother things aspects of the ResMed Limited MIRAGE LIBERTY™ full-facemask); International Patent Application WO 2009/052,560 (describingamongst other things aspects of the ResMed Limited SWIFT™ FX nasalpillows).

5.2.3.1.2 Positioning and Stabilising

A seal-forming portion of a patient interface used for positive airpressure therapy is subject to the corresponding force of the airpressure to disrupt a seal. Thus a variety of techniques have been usedto position the seal-forming portion, and to maintain it in sealingrelation with the appropriate portion of the face.

One technique is the use of adhesives. See for example US PatentApplication Publication No. US 2010/0000534. However, the use ofadhesives may be uncomfortable for some.

Another technique is the use of one or more straps and/or stabilisingharnesses. Many such harnesses suffer from being one or more ofill-fitting, bulky, uncomfortable and awkward to use.

5.2.3.1.3 Patient Interface Sizing

Patient interfaces, as described above, may be provided to a patient invarious forms, such as a nasal mask or full-face mask/oro-nasal mask(FFM) or nasal pillows mask, for example. Such patient interfaces aremanufactured with various dimensions to accommodate a specific patient'sanatomical features in order to facilitate a comfortable interface thatis functional to provide, for example, positive pressure therapy. Suchpatient interface dimensions may be customized to correspond with aparticular patient's specific facial anatomy or may be designed toaccommodate a population of individuals that have an anatomy that fallswithin predefined spatial boundaries or ranges. However in some casesmasks may come in a variety of standard sizes from which a suitable onemust be chosen.

In this regard, sizing a patient interface for a patient is typicallyperformed by a trained individual, such as a Durable Medical Equipment(DME) provider or physician. Typically a patient needing a patientinterface to begin or continue positive pressure therapy would visit thetrained individual at an accommodating facility where a series ofmeasurements are made in an effort to determine an appropriate patientinterface size from standard sizes. An appropriate size is intended tomean a particular combination of dimensions of certain features, such asthe seal forming structure, of a patient interface, which provideadequate comfort and sealing to effectuate positive pressure therapy.Sizing in this way is not only labor intensive but also inconvenient.The inconvenience of taking time out of a busy schedule or, in someinstances, having to travel great distances is a barrier to manypatients receiving a new or replacement patient interface and ultimatelya barrier to receiving treatment. Nevertheless, selection of the mostappropriate size is important for treatment quality and compliance.

6 BRIEF SUMMARY OF THE TECHNOLOGY

The present technology is directed towards providing medical devicesused in the diagnosis, amelioration, treatment, or prevention ofrespiratory disorders having one or more of improved comfort, cost,efficacy, ease of use and manufacturability.

A first aspect of the present technology relates to apparatus used inthe diagnosis, amelioration, treatment or prevention of a respiratorydisorder.

Another aspect of the present technology relates to methods used in thediagnosis, amelioration, treatment or prevention of a respiratorydisorder.

An aspect of certain forms of the present technology is to providemethods and/or apparatus that improve the compliance of patients withrespiratory therapy.

One form of the present technology comprises automatic sizing of apatient interface without the assistance of a trained individual.

Another aspect of one form of the present technology is the automaticmeasurement of a patient's facial features based on data collected fromthe patient.

Another aspect of one form of the present technology is the automaticrecommendation of a patient interface size based on a comparison betweendata collected from a patient to a corresponding data record.

Another aspect of one form of the present technology is a mobileapplication that conveniently determines an appropriate patientinterface size for a particular patient based on a two-dimensionalimage.

Some versions of the present technology include automated method(s) forselecting a patient interface according to patient interface size. Themethod(s) may operate in one or more processors. The method may includereceiving image data captured by an image sensor. The captured imagedata may contain one or more facial features of an intended user of thepatient interface in association with a predetermined reference featurehaving a known dimension. The method may include detecting one or morefacial features of the user in the captured image data. The method mayinclude detecting the predetermined reference feature in the capturedimage data. The method may include processing image pixel data of theimage to measure an aspect of the one or more facial features detectedin the image based on the predetermined reference feature. The methodmay include selecting a patient interface size from a group of standardpatient interface sizes based on a comparison between the measuredaspect of the one or more facial features and a data record relatingsizing information of the group of standard patient interface sizes andthe measured aspect of the one or more facial features.

In some versions, the aspect of the one or more facial features mayinclude a distance between a sellion and supramenton of the user. Themethod may include calculating a value of the measured aspect based on ascaling factor derived from the reference feature. The method mayinclude adjusting a value of the measured aspect with an anthropometriccorrection factor. The anthropometric correction factor may becalculated based on patient interface return data. The method mayinclude calculating the scaling factor as a function of the knowndimension of the predetermined reference feature and a detected pixelcount for the detected reference feature. The predetermined referencefeature may be a coin. The detecting the reference feature may includeapplying a cascade classifier to the captured image data. The method mayinclude calculating a value of the measured aspect based on a scalingfactor derived from the coin. The method may include calculating thescaling factor as a function of the known dimension of the coin in thecaptured image data and a detected pixel count for the coin that isdetected. The detected pixel count for the coin that is detected may bea width of an ellipse fitted to the coin. The predetermined referencefeature may be a cornea of the user.

In some versions, the method may include, for image capture, displayingthe reference feature on a display interface of a display device coupledwith the image sensor. The display interface may include a targetingguide and a live action preview of content detected by the image sensor.The content may include the reference feature as displayed on thedisplay interface. The method may include controlling capturing of theimage data to satisfy at least one alignment condition. The at least onealignment condition may include detection of positioning of thereference feature of the live action preview within a box of thetargeting guide. The at least one alignment condition may includedetection of a tilt condition being within about +/−10 degrees of asuperior-inferior extending axis. The at least one alignment conditionmay include detection of a tilt condition being within about +/−5degrees of a superior-inferior extending axis. Detection of a tiltcondition may be performed by reading an inertial measurement unit(IMU).

In some versions, the predetermined reference feature may be a QR code.The patient interface may include a mask. The patient interface mayinclude a nasal mask. Optionally, the processing image pixel data mayinclude counting pixels. The method may include generating an automatedelectronic offer for a patient interface for purchase based on theselected patient interface size. The method may include calculating anaverage of the measured aspect of the facial feature from a plurality ofcaptured images of the one or more facial features.

Some versions of the present technology include a system(s) forautomatically recommending a patient interface size complementary to aparticular patient's facial features. The system(s) may include one ormore servers. The one or more servers may be configured to communicatewith a computing device over a network. The one or more servers may beconfigured to receive image data captured by an image sensor, where thecaptured image data may contain one or more facial features of anintended user of the patient interface in association with apredetermined reference feature having a known dimension. The one ormore servers may be configured to detect one or more facial features ofthe user in the captured image data. The one or more servers may beconfigured to detect the predetermined reference feature in the capturedimage data. The one or more servers may be configured to process imagepixel data of the image to measure an aspect of the one or more facialfeatures detected in the image based on the predetermined referencefeature. The one or more servers may be configured to select a patientinterface size from a group of standard patient interface sizes based ona comparison between the measured aspect of the one or more facialfeatures and a data record relating sizing information of the group ofstandard patient interface sizes and the measured aspect of the one ormore facial features.

In some versions, the aspect of the one or more facial features mayinclude a distance between a sellion and supramenton of the user. Theone or more servers may be configured to calculate a value of themeasured aspect based on a scaling factor derived from the referencefeature. The one or more servers may be configured to adjust a value ofthe measured aspect with an anthropometric correction factor. Theanthropometric correction factor may be calculated based on patientinterface return data. The one or more servers may be configured tocalculate the scaling factor as a function of the known dimension of thepredetermined reference feature and a detected pixel count for thedetected reference feature. The predetermined reference feature mayinclude a coin. The one or more servers may be configured to detect thereference feature by applying a cascade classifier to the captured imagedata. The one or more servers may be further configured to calculate avalue of the measured aspect based on a scaling factor derived from thecoin. The one or more servers may be configured to calculate the scalingfactor as a function of the known dimension of the coin in the capturedimage data and a detected pixel count for the coin that is detected. Thedetected pixel count for the coin that is detected may be a width of anellipse fitted to the coin. The predetermined reference feature may be acornea of the user.

In some versions, the system may include the computing device. Thecomputing devices may be configured to, for image capture, generate adisplay of the reference feature on a display interface of a displaydevice that may be coupled with the image sensor. The display interfacemay include a targeting guide and a live action preview of contentdetected by the image sensor. The content may include the referencefeature as displayed on the display interface. The computing device maybe further configured to control capturing of the image data to satisfyat least one alignment condition. The at least one alignment conditionmay include detection of positioning of the reference feature of thelive action preview within a box of the targeting guide. The at leastone alignment condition may include detection of a tilt condition beingwithin about +/−10 degrees of a superior-inferior extending axis. The atleast one alignment condition may include detection of a tilt conditionbeing within about +/−5 degrees of a superior-inferior extending axis.The detection of a tilt condition may be performed by reading aninertial measurement unit (IMU).

In some versions, the predetermined reference feature may include a QRcode. The patient interface may include a mask. The patient interfacemay include a nasal mask. In some cases, to process image pixel data,the one or more servers may be configured to count pixels. The one ormore servers may be configured to generate an automated electronic offerfor a patient interface for purchase based on the selected patientinterface size. The one or more servers may be configured to calculatean average of the measured aspect of the facial feature from a pluralityof captured images of the facial features. The one or more servers maybe configured to communicate the selected patient interface size to thecomputing device over the network.

Some versions of the present technology include a system(s) forautomatically recommending a patient interface size complementary to aparticular patient's facial features. The system(s) may include a mobilecomputing device. The mobile computing device may be configured tocommunicate with one or more servers over a network. The mobilecomputing device may be configured to receive captured image data of animage. The captured image data may contain one or more facial featuresof a user in association with a predetermined reference feature having aknown dimension. The image data may be captured with an image sensor.The mobile computing device may be configured to detect one or morefacial features of the user in the captured image data. The mobilecomputing device may be configured to detect the predetermined referencefeature in the captured image data. The mobile computing device may beconfigured to process image pixel data of the image to measure an aspectof the one or more facial features detected in the image based on thepredetermined reference feature. The mobile computing device may beconfigured to select a patient interface size from a group of standardpatient interface sizes based on a comparison between the measuredaspect of the one or more facial features and a data record relatingsizing information of the group of standard patient interface sizes andthe measured aspect of the one or more facial features.

In some versions, the aspect of the one or more facial features mayinclude a distance between a sellion and supramenton of the user. Themobile computing device may be configured to calculate a value of themeasured aspect based on a scaling factor derived from the referencefeature. The mobile computing device may be further configured to adjusta value of the measured aspect with an anthropometric correction factor.The anthropometric correction factor may be calculated based on patientinterface return data. The mobile computing device may be configured tocalculate the scaling factor as a function of the known dimension of thepredetermined reference feature and a detected pixel count for thedetected reference feature. The predetermined reference feature may be acoin. The mobile computing device may be configured to detect thereference feature by applying a cascade classifier to the captured imagedata. The mobile computing device may be configured to calculate a valueof the measured aspect based on a scaling factor derived from the coin.The mobile computing device may be configured to calculate the scalingfactor as a function of the known dimension of the coin in the capturedimage data and a detected pixel count for the coin that is detected. Thedetected pixel count for the coin that is detected may be a width of anellipse fitted to the coin. In some versions, the predeterminedreference feature may be a cornea of the user. T

The mobile computing device may be configured to, for the image capture,generate a display of the reference feature on a display interface of adisplay device that may be coupled with the image sensor. The displayinterface may include a targeting guide and a live action preview ofcontent detected by the image sensor. The content may include thereference feature as displayed on the display interface. The mobilecomputing device may be configured to control capturing of the imagedata to satisfy at least one alignment condition. The at least onealignment condition may include detection of positioning of thereference feature of the live action preview within a box of thetargeting guide. The at least one alignment condition may includedetection of a tilt condition being within about +/−10 degrees of asuperior-inferior extending axis. The at least one alignment conditionmay include detection of a tilt condition being within about +/−5degrees of a superior-inferior extending axis. Detection of a tiltcondition may be performed by reading an inertial measurement unit(IMU).

In some versions, the predetermined reference feature may be a QR code.The patient interface may be a mask. The patient interface may be anasal mask. In some cases, to process image pixel data, the mobilecomputing device may be configured to count pixels. The mobile computingdevice may be configured to request an automated electronic offer for apatient interface for purchase based on the selected patient interfacesize. The mobile computing device may be configured to calculate anaverage of the measured aspect of the facial feature from a plurality ofcaptured images of the facial features. The mobile computing device maybe configured to communicate the selected patient interface size to aserver over the network.

Some versions of the present technology include apparatus forautomatically recommending a patient interface size complementary to aparticular patient's facial features. The apparatus may include meansfor receiving image data captured by an image sensor. The captured imagedata may contain one or more facial features of an intended user of thepatient interface in association with a predetermined reference featurehaving a known dimension. The apparatus may include means for detectingone or more facial features of the user in the captured image data. Theapparatus may include means for detecting the predetermined referencefeature in the captured image data. The apparatus may include means forprocessing image pixel data of the image to measure an aspect of the oneor more facial features detected in the image based on the predeterminedreference feature. The apparatus may include means for selecting apatient interface size from a group of standard patient interface sizesbased on a comparison between the measured aspect of the one or morefacial features and a data record relating sizing information of thegroup of standard patient interface sizes and the measured aspect of theone or more facial features.

Of course, portions of the aspects may form sub-aspects of the presenttechnology. Also, various ones of the sub-aspects and/or aspects may becombined in various manners and also constitute additional aspects orsub-aspects of the present technology.

Other features of the technology will be apparent from consideration ofthe information contained in the following detailed description,abstract, drawings and claims.

7 BRIEF DESCRIPTION OF THE DRAWINGS

The present technology is illustrated by way of example, and not by wayof limitation, in the figures of the accompanying drawings, in whichlike reference numerals refer to similar elements including:

7.1 Treatment Systems

FIG. 1A shows a system including a patient wearing a patient interfacein the form of a nasal pillow;

FIG. 1B shows a system including a patient wearing a patient interfacein the form of a nasal mask;

FIG. 1C shows a system including a patient wearing a patient interfacein the form of a full-face mask;

FIG. 2 shows a patient interface in the form of a nasal mask withheadgear in accordance with one form of the present technology.

FIG. 3A is a front view of a face with several features of surfaceanatomy identified including the lip superior, upper vermilion, lowervermilion, lip inferior, mouth width, endocanthion, a nasal ala,nasolabial sulcus and cheilion. Also indicated are the directionssuperior, inferior, radially inward and radially outward.

FIG. 3B is a side view of a head with several features of surfaceanatomy identified including glabella, sellion, pronasale, subnasale,lip superior, lip inferior, supramenton, nasal ridge, alar crest point,otobasion superior and otobasion inferior. Also indicated are thedirections superior & inferior, and anterior & posterior.

FIG. 3C is a base view of a nose with several features identifiedincluding naso-labial sulcus, lip inferior, upper Vermilion, naris,subnasale, columella, pronasale, the major axis of a naris and thesagittal plane.

FIG. 4 is a diagram of an example system for automatically sizing apatient interface which includes a computing device.

FIG. 5 is a block diagram of an example architecture of a computingdevice for the system of FIG. 4 including example components suitablefor implementing the methodologies of the present technology.

FIG. 6A is a flow diagram of a pre-capture phase method of an exampleversion of the present technology.

FIG. 6B is a flow diagram of a capture phase method of some versions ofthe present technology.

FIG. 6C is a flow diagram of a post-capture image processing phasemethod of some versions of the present technology.

FIG. 6D is a flow diagram of a comparison and output phase method ofsome versions of an exemplary method embodiment of the presenttechnology.

FIG. 7A shows an example display interface for some versions of thepresent technology.

FIG. 7B shows another example display interface for some versions of thepresent technology.

FIG. 7C illustrates a user employing a method of the present technology.

FIG. 8 is a flow diagram of a method of implementing the post-captureimage processing phase according to a further implementation of thepresent technology.

FIG. 9 is a flow chart illustrating a method of implementing the facialfeature detection step of the method of FIG. 8.

FIG. 10 is a flow chart illustrating a method of implementing thereference feature detection step of the method of FIG. 8.

FIG. 11 is a flow chart illustrating a method of implementing thescaling factor calculation step of the method of FIG. 8.

FIG. 12 is a flow chart illustrating a method of implementing the facialfeature measurement step of the method of FIG. 8.

FIG. 13A is an illustration of the positioning of a coin on the user'sforehead according to the further implementation of the presenttechnology.

FIG. 13B is an illustration of the detected boxes and consequent facialfeature measurement according to the method of FIG. 8.

FIG. 14 is an illustration of the detected facial features in a capturedimage according to an alternative implementation of the method of FIG.8.

8 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

Before the present technology is described in further detail, it is tobe understood that the technology is not limited to the particularexamples described herein, which may vary. It is also to be understoodthat the terminology used in this disclosure is for the purpose ofdescribing only the particular examples discussed herein, and is notintended to be limiting.

The following description is provided in relation to various exampleswhich may share one or more common characteristics and/or features. Itis to be understood that one or more features of any one example may becombinable with one or more features of another example or otherexamples. In addition, any single feature or combination of features inany of the examples may constitute a further example.

8.1 Treatment Systems

In one form, the present technology comprises an apparatus or device fortreating a respiratory disorder. The apparatus or device may comprise anRPT device 40 for supplying pressurised air to the patient 10 via an aircircuit 50 to a patient interface 100.

FIG. 1A shows a system including a patient 10 wearing a patientinterface 100, in the form of nasal pillows, receives a supply of air atpositive pressure from a RPT device 40. Air from the RPT device ishumidified in a humidifier 60, and passes along an air circuit 50 to thepatient 10. A bed partner 20 is also shown.

FIG. 1B shows a system including a patient 10 wearing a patientinterface 100, in the form of a nasal mask, receives supply air atpositive pressure from an RPT device 40. Air from the RPT device ishumidified in a humidifier 60, and passes along an air circuit 50 to thepatient 10.

FIG. 1C shows a system including a patient 10 wearing a patientinterface 100, in the form of a full-face mask (FFM), receives a supplyof air at positive pressure from a RPT device 40. Air from the RPTdevice is humidified in a humidifier 60, and passes along an air circuit50 to the patient 10.

8.2 Patient Interface

FIG. 2 depicts a patient interface 100 in accordance with one aspect ofthe present technology comprises the following functional aspects: aseal-forming structure 160, a plenum chamber 120, a positioning andstabilising structure 130, a vent 140, a forehead support 150, one formof connection port 170 for connection to air circuit 50. In some forms afunctional aspect may be provided by one or more physical components. Insome forms, one physical component may provide one or more functionalaspects. In use the seal-forming structure 160 is arranged to surroundan entrance to the airways of the patient so as to facilitate the supplyof air at positive pressure to the airways.

8.2.1 Seal-Forming Structure

In one form of the present technology, a seal-forming structure 160provides a seal-forming surface, and may additionally provide acushioning function.

A seal-forming structure 160 in accordance with the present technologymay be constructed from a soft, flexible, resilient material such assilicone.

In one form the seal-forming portion of the non-invasive patientinterface 100 comprises a pair of nasal puffs, or nasal pillows, eachnasal puff or nasal pillow being constructed and arranged to form a sealwith a respective naris of the nose of a patient.

Nasal pillows in accordance the present technology include: afrusto-cone, at least a portion of which forms a seal on an underside ofthe patient's nose, a stalk, a flexible region on the underside of thefrusto-cone and connecting the frusto-cone to the stalk. In addition,the structure to which the nasal pillow of the present technology isconnected includes a flexible region adjacent the base of the stalk. Theflexible regions can act in concert to facilitate a universal jointstructure that is accommodating of relative movement both displacementand angular of the frusto-cone and the structure to which the nasalpillow is connected. For example, the frusto-cone may be axiallydisplaced towards the structure to which the stalk is connected.

In one form, the non-invasive patient interface 100 comprises aseal-forming portion that forms a seal in use on an upper lip region(that is, the lip superior) of the patient's face.

In one form the non-invasive patient interface 100 comprises aseal-forming portion that forms a seal in use on a chin-region of thepatient's face.

8.2.2 Plenum Chamber

Preferably the plenum chamber 120 has a perimeter that is shaped to becomplementary to the surface contour of the face of an average person inthe region where a seal will form in use. In use, a marginal edge of theplenum chamber 120 is positioned in close proximity to an adjacentsurface of the face. Actual contact with the face is provided by theseal-forming structure 160. The seal-forming structure 160 may extend inuse about the entire perimeter of the plenum chamber 120.

8.2.3 Positioning and Stabilising Structure

Preferably the seal-forming structure 160 of the patient interface 100of the present technology may be held in sealing position in use by thepositioning and stabilising structure 130.

8.2.4 Vent

In one form, the patient interface 100 includes a vent 140 constructedand arranged to allow for the washout of exhaled carbon dioxide.

One form of vent 140 in accordance with the present technology comprisesa plurality of holes, for example, about 20 to about 80 holes, or about40 to about 60 holes, or about 45 to about 55 holes.

8.2.5 Terms Used in Relation to a Patient Interface

Plenum chamber: a mask plenum chamber will be taken to mean a portion ofa patient interface having walls enclosing a volume of space, the volumehaving air therein pressurised above atmospheric pressure in use. Ashell may form part of the walls of a mask plenum chamber.

Seal: The noun form (“a seal”) will be taken to mean a structure orbarrier that intentionally resists the flow of air through the interfaceof two surfaces. The verb form (“to seal”) will be taken to mean toresist a flow of air.

8.3 Anatomy of the Face

FIG. 3A shows an anterior view of a human face including theendocanthion, nasal ala, nasolabial sulcus, lip superior and inferior,upper and lower vermillion, and chelion. Also shown are the mouth width,the sagittal plane dividing the head into left and right portions, anddirectional indicators. The directional indicators indicate radialinward/outward and superior/inferior directions.

FIG. 3B shows a lateral view of a human face including the glabaella,sellion, nasal ridge, pronasale, subnasale, superior and inferior lip,supramenton, alar crest point, and otobasion superior and inferior. Alsoshown are directional indictors indicating superior/inferior andanterior/posterior directions.

FIG. 3C shows a base view of a nose with several features identifiedincluding naso-labial sulcus, lip inferior, upper Vermilion, naris,subnasale, columella, pronasale, the major axis of a naris and thesagittal plane.

8.3.1 Terms Used in Relation to the Anatomy of the Face

Ala: the external outer wall or “wing” of each nostril (plural: alar)

Alare: The most lateral point on the nasal ala.

Alar curvature (or alar crest) point: The most posterior point in thecurved base line of each ala, found in the crease formed by the union ofthe ala with the cheek.

Auricle: The whole external visible part of the ear.

Columella: the strip of skin that separates the nares and which runsfrom the pronasale to the upper lip.

Columella angle: The angle between the line drawn through the midpointof the nostril aperture and a line drawn perpendicular to the Frankfurthorizontal while intersecting subnasale.

Glabella: Located on the soft tissue, the most prominent point in themidsagittal plane of the forehead.

Nares (Nostrils): Approximately ellipsoidal apertures forming theentrance to the nasal cavity. The singular form of nares is naris(nostril). The nares are separated by the nasal septum.

Naso-labial sulcus or Naso-labial fold: The skin fold or groove thatruns from each side of the nose to the corners of the mouth, separatingthe cheeks from the upper lip.

Naso-labial angle: The angle between the columella and the upper lip,while intersecting subnasale.

Otobasion inferior: The lowest point of attachment of the auricle to theskin of the face.

Otobasion superior: The highest point of attachment of the auricle tothe skin of the face.

Pronasale: the most protruded point or tip of the nose, which can beidentified in lateral view of the rest of the portion of the head.

Philtrum: the midline groove that runs from lower border of the nasalseptum to the top of the lip in the upper lip region.

Pogonion: Located on the soft tissue, the most anterior midpoint of thechin.

Ridge (nasal): The nasal ridge is the midline prominence of the nose,extending from the Sellion to the Pronasale.

Sagittal plane: A vertical plane that passes from anterior (front) toposterior (rear) dividing the body into right and left halves.

Sellion: Located on the soft tissue, the most concave point overlyingthe area of the frontonasal suture.

Septal cartilage (nasal): The nasal septal cartilage forms part of theseptum and divides the front part of the nasal cavity.

Subalare: The point at the lower margin of the alar base, where the alarbase joins with the skin of the superior (upper) lip.

Subnasal point: Located on the soft tissue, the point at which thecolumella merges with the upper lip in the midsagittal plane.

Supramenton: The point of greatest concavity in the midline of the lowerlip between labrale inferius and soft tissue pogonion

8.4 Automatic Patient Interface Sizing 8.4.1 Overview

Obtaining a patient interface allows a patient to engage in positivepressure therapy. Patients seeking their first patient interface or anew patient interface to replace an older interface, typically consult aDME to determine a recommended patient interface size based onmeasurements of the patient's facial anatomy, which are typicallyperformed by the DME. This may be an inconvenience that prevents somepatients from receiving a needed patient interface and from engaging inpositive pressure therapy. The present technology allows patients tomore quickly and conveniently obtain a patient interface. It may permita more efficient method to quickly measure their facial anatomy andreceive a recommendation for an appropriate patient interface size fromthe comfort of their own home using a computing device, such as adesktop computer, tablet, smart phone or other mobile device.

In a beneficial embodiment, the present technology may employ anapplication downloadable from a manufacturer or third party server to asmartphone or tablet with an integrated camera. When launched, theapplication may provide visual and/or audio instructions. As instructed,the user (i.e. a patient) may stand in front of a mirror 330, and pressthe camera button on a user interface. An activated process may thentake a series of pictures of the user's face, and then, within a matterof seconds for example, recommend a patient interface size for the user(based on the processor analysing the pictures). This is a vastimprovement over the traditional method of visiting a DME who takes aseries of measurements with a calliper as it allows a user, anywhere inthe world, to quickly and conveniently find a patient interface suitablefor their needs. Thus, it can allow patients to begin treatment morerapidly. Moreover, in that the user has control over the process, thecustomer can repeat it if desired, unhurriedly and to theirsatisfaction, increasing the user's confidence and sense ofresponsibility.

As described further below, the present technology allows a user/patientto capture an image or series of images of their facial structure.Instructions provided by an application stored on a computer-readablemedium, such as when executed by a processor, detect various faciallandmarks within the images, measure and scale the distance between suchlandmarks, compare these distances to a data record, and recommend anappropriate patient interface size. Thus, an automated device of aconsumer may permit accurate patient interface selection, such as in thehome, to permit customers to determine sizing without trainedassociates.

8.4.2 System

FIG. 4 depicts an example system 200 that may be implemented forautomatic facial feature measuring and patient interface sizing. System200 may generally include one or more of servers 210, a communicationnetwork 220, and a computing device 230. Server 210 and computing device230 may communicate via communication network 220, which may be a wirednetwork 222, wireless network 224, or wired network with a wireless link226. In some versions, server 210 may communicate one-way with computingdevice 230 by providing information to computing device 230, or viceversa. In other embodiments, server 210 and computing device 230 mayshare information and/or processing tasks. The system may beimplemented, for example, to permit automated purchase of patient'sinterfaces (mask) where the process may include automatic sizingprocesses described in more detail herein. For example, a customer mayorder a mask online after running a mask selection process thatautomatically identifies a suitable mask size by image analysis of thecustomer's facial features.

8.4.2.1 Computing Device

Computing device 230 can be a desktop or laptop computer 232 or a mobiledevice, such as a smartphone 234 or tablet 236. FIG. 5 depicts thegeneral architecture 300 of computing device 230. Device 230 may includeone or more processors 310. Device 230 may also include a displayinterface 320, user control/input interface 331, sensor 340 and/or asensor interface for one or more sensor(s), inertial measurement unit(IMU) 342 and non-volatile memory/data storage 350.

Sensor 340 may be one or more cameras (e.g., a CCD charge-coupled deviceor active pixel sensors) that are integrated into computing device 230,such as those provided in a smartphone or in a laptop. Alternatively,where computing device 230 is a desktop computer, device 230 may includea sensor interface for coupling with an external camera, such as thewebcam 233 depicted in FIG. 4. Other exemplary sensors that could beused to assist in the methods described herein that may either beintegral with or external to the computing device include stereoscopiccameras, for capturing three-dimensional images, or a light detectorcapable of detecting reflected light from a laser or strobing/structuredlight source.

User control/input interface 331 allows the user to provide commands orrespond to prompts or instructions provided to the user. This could be atouch panel, keyboard, mouse, microphone, and/or speaker, for example.

Display interface 320 may include a monitor, LCD panel, or the like todisplay prompts, output information (such as facial measurements orinterface size recommendations), and other information, such as acapture display, as described in further detail below.

Memory/data storage 350 may be the computing device's internal memory,such as RAM, flash memory or ROM. In some embodiments, memory/datastorage 350 may also be external memory linked to computing device 230,such as an SD card, server, USB flash drive or optical disc, forexample. In other embodiments, memory/data storage 350 can be acombination of external and internal memory. Memory/data storage 350includes stored data 354 and processor control instructions 352 thatinstruct processor 310 to perform certain tasks. Stored data 354 caninclude data received by sensor 340, such as a captured image, and otherdata that is provided as a component part of an application. Processorcontrol instructions 352 can also be provided as a component part of anapplication.

8.4.2.2 Application for Facial Feature Measuring and Patient InterfaceSizing

One such application is an application for facial feature measuringand/or patient interface sizing 360, which may be an applicationdownloadable to a mobile device, such as smartphone 234 and/or tablet236. The application 360, which may be stored on a computer-readablemedium, such as memory/data storage 350, includes programmedinstructions for processor 310 to perform certain tasks related tofacial feature measuring and/or patient interface sizing. Theapplication also includes data that may be processed by the algorithm ofthe automated methodology. Such data may include a data record,reference feature, and correction factors, as explained in additionaldetail below.

8.4.3 Method for Automatic Measuring and Sizing

As illustrated in the flow diagrams of FIGS. 6A-6D, one aspect of thepresent technology is a method for controlling a processor, such asprocessor 310, to measure patient facial features using two-dimensionalor three-dimensional images and to recommend or select an appropriatepatient interface size, such as from a group of standard sizes, based onthe resultant measurements. The method may generally be characterized asincluding three or four different phases: a pre-capture phase 400, acapture phase 500, a post-capture image processing phase 600, and acomparison and output phase 700.

In some cases, the application for facial feature measuring and patientinterface sizing may control a processor 310 to output a visual displaythat includes a reference feature on the display interface 320. The usermay position the feature adjacent to their facial features, such as bymovement of the camera. The processor may then capture and store one ormore images of the facial features in association with the referencefeature when certain conditions, such as alignment conditions aresatisfied. This may be done with the assistance of a mirror 330. Themirror 330 reflects the displayed reference feature and the user's faceto the camera. The application then controls the processor 310 toidentify certain facial features within the images and measure distancestherebetween. By image analysis processing a scaling factor may then beused to convert the facial feature measurements, which may be pixelcounts, to standard mask measurement values based on the referencefeature. Such values may be, for example, standardized unit of measure,such as a meter or an inch, and values expressed in such units suitablefor mask sizing. Additional correction factors may be applied to themeasurements. The facial feature measurements may be compared to datarecords that include measurement ranges corresponding to differentpatient interface sizes for particular patient interface forms, such asnasal masks and FFM's, for example. The recommended size may then bechosen and be output to the user/patient based on the comparison(s) as arecommendation. Such a process may be conveniently effected within thecomfort of the user's own home, if the user so chooses. The applicationmay perform this method within seconds. In one example, the applicationperforms this method in real time.

8.4.3.1 Pre-Capture Phase 400

In the pre-capture phase, which is represented by the flow diagram ofFIG. 6A, processor 310, among other things, assists the user inestablishing the proper conditions for capturing one or more images forsizing processing. Some of these conditions include proper lighting andcamera orientation and motion blur caused by an unsteady hand holdingthe computing device 230, for example.

In one version of the method, a user may conveniently download anapplication for performing the automatic measuring and sizing atcomputing device 230 from a server, such as a third partyapplication-store server, onto their computing device 230. Whendownloaded, such application may be stored on the computing device'sinternal non-volatile memory, such as RAM or flash memory. Computingdevice 230 is preferably a mobile device, such as smartphone 234 ortablet 236. When the user launches the application, processor 310 mayprompt the user via the computing device's display interface 320 toprovide patient specific information, such as age, gender, weight, andheight. However, processor 310 may prompt to the user to input thisinformation at any time, such as after the user's facial features aremeasured. Processor 310 may also present a tutorial, which may bepresented audibly and/or visually, as provided by the application to aidthe user in understanding their role during the process. The prompts mayalso require information for patient interface type, e.g. nasal or fullface, etc. and of the type of device for which the patient interfacewill be used. Also, in the pre-capture phase 400, the application mayextrapolate the patient specific information based on informationalready gathered by the user, such as after receiving captured images ofthe user's face, and based on machine learning techniques or throughartificial intelligence.

8.4.3.1.1 Sensor Activation 410

When the user is prepared to proceed, which may be indicated by a userinput or response to a prompt via user control/input interface 331,processor 310 activates sensor 340 as instructed by the application'sprocessor control instructions 352. Sensor 340 is preferably the mobiledevice's forward facing camera, which is located on the same side of themobile device as display interface 320. The camera is generallyconfigured to capture two-dimensional images. Mobile device cameras thatcapture two-dimensional images are ubiquitous. The present technologytakes advantage of this ubiquity to avoid burdening the user with theneed to obtain specialized equipment.

8.4.3.1.2 Display 420

Around the same time sensor/camera 340 is activated, processor 310, asinstructed by the application, presents a capture display on the displayinterface 320. FIG. 7A depicts an example of a capture display 322 andof contents thereof, which may include a camera live action preview 324,a reference feature 326, a targeting box 328, and one or more statusindicators 327 or any combination thereof. In this example, thereference feature 326 is displayed centred on the display interface andhas a width corresponding to the width of the display interface 320. Thevertical position of the reference feature 326 may be such that the topedge of reference feature 326 abuts the upper most edge of the displayinterface 320 or the bottom edge of reference feature 326 abuts thelower most edge of the display interface 320. A portion of the displayinterface 320 will display the camera live action preview 324, typicallyshowing the user's facial features captured by sensor/camera 340 in realtime if the user is in the correct position and orientation.

Live action preview 324 is a stream of images/content seen/detected bythe camera/sensor 340 in, for example, real time. Thus, if the userdirects the front facing camera 340 toward the user's facial features,the user's facial features may be presented on display interface 320.Similarly, if the user directs the front facing camera 340 toward amirror 330, the reflection in the mirror 330, which would preferablyinclude the display interface 320 and one or more of its contentsincluding the reference feature 326, is displayed on the displayinterface 320 as part of live action preview 324. However, it should beunderstood that, while live action preview 324 can include the patient'sfacial features, it is not necessary to display such facial features ondisplay interface 320, as is illustrated by FIG. 7A. Nevertheless, thesensor 340 does capture the facial features during this aspect of theprocess.

Reference feature 326 is a feature that is known to computing device 230(predetermined) and provides a frame of reference to processor 310 thatallows processor 310 to scale captured images. The reference feature maypreferably be a feature other than a facial or anatomical feature of theuser. Thus, during the image processing phase 600, it assists processor310 in determining when certain alignment conditions are satisfied, suchas during the pre-capture phase 400. As shown in FIG. 7A, referencefeature 326 may be a quick response (QR) code or known exemplar ormarker, which can provide processor 310 certain information, such asscaling information, orientation, and/or any other desired informationwhich can optionally be determined from the structure of the QR code.The QR code may have a square or rectangular shape. When displayed ondisplay interface 320, reference feature 326 has predetermineddimensions, such as in units of millimeters or centimeters, the valuesof which may be coded into the application and communicated to processor310 at the appropriate time. The actual dimensions of reference feature326 may vary between various computing devices. In some versions, theapplication may be configured to be a computing device model-specific inwhich the dimensions of reference feature 326, when displayed on theparticular model, is already known. However, in other embodiments, theapplication may instruct processor 310 to obtain certain informationfrom device 230, such as display size and/or zoom characteristics thatallow the processor 310 to compute the real world/actual dimensions ofreference feature 326 as displayed on display interface 320 via scaling.Regardless, the actual dimensions of reference feature 326 as displayedon the display interfaces 320 of such computing devices are generallyknown prior to post-capture image processing.

Along with reference feature 326, targeting box 328 may be displayed ondisplay interface 320 and overlie live action preview 324. Targeting box328 allows the user to align certain components within capture display322 in targeting box 328, which is desired for successful image capture.In one example illustrated by FIG. 7A, the application may include acapture condition that reference feature 326 will be entirely withintarget box 328 prior to image capture. Alignment of reference feature326 within targeting box 328 may improve detection during laterprocessing and ensure good position and alignment of reference feature326 within the captured image. Additionally, alignment within targetingbox 328 may help to ensure display interface 320 alignment along asuperior-inferior axis so as to avoid excessive radial inward or outwardtilt and rotationally about the superior-inferior axis to maintaindisplay interface 320 generally parallel with a mirror 330, for example.

The status indicator 327 provides information to the user regarding thestatus of the process. This helps ensure the user does not make majoradjustments to the positioning of the sensor/camera prior to completionof image capture.

Thus, in the embodiment depicted in FIG. 7A, when the user holds displayinterface 320 parallel to the facial features to be measured andpresents user display interface 320 to a mirror 330 or other reflectivesurface, reference feature 326 is prominently displayed and overlays thereal-time images seen by camera/sensor 340 and as reflected by themirror 330. This reference feature 326 may be fixed near the top ofdisplay interface 320. Reference feature 326 is prominently displayed inthis manner at least partially so that sensor 340 can clearly seereference feature 326 so that processor 310 can easily identify feature326. In addition, reference feature 326 may overlay the live view of theuser's face, which helps avoid user confusion. A moveable referencefeature image 329, which is a real-time live view reflection ofreference feature 326, is positionable within the alignment box bymovement of the display device having the image sensor. Ultimately, whenmovable reference feature image 329 is positioned within targeting box328, alignment box and moveable reference feature image 329 will bepositioned and aligned in an offset manner relative to reference feature326 (e.g., directly below), which facilitates usability.

Other features or information can be displayed by processor 310 ondisplay interface 320. For instance, the application may establishparameters that must be satisfied regarding lighting conditions. Iflighting conditions are unsatisfactory, processor 310 may display awarning on the display interface or output an audible warning to theuser and instruct the user on steps that can be taken that can helprectify the unsatisfactory lighting conditions.

FIG. 7B illustrates an alternative capture display embodiment 320 a,which similarly includes a targeting box 328 and a reference feature326. However, unlike FIG. 7A, live action preview 324 shows the user'sface, which in this case is alternatively designated for placementwithin targeting box 328, rather than being designated to containreference feature 326. Further, display 320 a also includes detectionpoints 321 and bounding boxes 323 generated by the processor 310.Processor 310, controlled by instructions from the application, maydetect and identify certain facial features in live action preview 324.These may be displayed for the user using detection points 321 andbounding boxes 323. This may help the user know that certain conditions,such as lighting, are satisfactory for image capture as it indicatesthat processor 310 is identifying these facial features with detectionpoints 321 and bounding them in bounding boxes 323.

8.4.3.1.3 Planar Alignment and Reflected Image 430

As depicted in FIG. 7C, the user may position themselves or their faceand computing device 230 in front of a mirror 330 such that the user'sfacial features and display interface 320 are reflected back to sensor340. The user may also be instructed by processor 310, via displayinterface 320, by audible instructions via a speaker of the computingdevice 230, or be instructed ahead of time by the tutorial, to positiondisplay interface 320 in a plane of the facial features to be measured.For example, the user may instructed to position display interface 320such that it is facing anteriorly and placed under, against, or adjacentto the user's chin in a plane aligned with certain facial features to bemeasured. For example, display interface 320 may be placed in planaralignment with the sellion and suprementon. As the images ultimatelycaptured are two-dimensional, planar alignment 430 helps ensure that thescale of reference feature 326 is equally applicable to the facialfeature measurements. In this regard, the distance between the mirror330 and both of the user's facial features and the display will beapproximately the same.

8.4.3.1.4 Detecting Reference Feature 440

When the user is positioned in front of a mirror 330 and displayinterface 320, which includes reference feature 326, is roughly placedin planar alignment with the facial features to be measured, processor310 checks for certain conditions to help ensure sufficient alignment.One exemplary condition that may be established by the application, aspreviously mentioned, is that the entirety of reference feature 326 mustbe detected within targeting box 328 in order to proceed. If processor310 detects that reference feature 326 is not entirely positioned withintargeting box 328, processor may 310 prohibit or delay image capture.The user may then move their face along with display interface 320 tomaintain planarity until reference feature 326, as displayed in the liveaction preview, is located within targeting box 328. This helpsoptimized alignment of the facial features and display interface 320with respect to mirror 330 for image capture.

8.4.3.1.5 Reading IMU & Tilt Alignment 450

When processor 310 detects the entirety of reference feature 326 withintargeting box 328, processor 310 may read the computing device's IMU 342for detection of device tilt angle, provided that computing device 230includes an IMU 342. The IMU 342 may include an accelerometer orgyroscope, for example. Thus the processor 310 may evaluate device tiltsuch as by comparison against one or more thresholds to ensure it is ina suitable range. For example, if it is determined that computing device230, and consequently display interface 320 and user's facial features,is tilted in any direction within about +/'5 degrees, the process mayproceed to the capture phase 500. In other embodiments, the tilt anglefor continuing may be within about +/−10 degrees, +/−7 degrees, +/−3degrees, or +/−1 degree. If excessive tilt is detected a warning messagemay be displayed or sounded to correct the undesired tilt. This isparticularly useful for assisting the user to help prohibit or reduceexcessive tilt, particularly in the anterior-posterior direction, whichif not corrected, could pose as a source of measuring error as thecaptive reference image will not have a proper aspect ratio.

8.4.3.2 Capture Phase 500 8.4.3.2.1 Capture Initiation 510

When alignment has been determined by processor 310 as controlled by theapplication, processor 310 proceeds into the capture phase 500. Thisphase 500 preferably occurs automatically once the alignment parametersand any other conditions precedent are satisfied. However, in someembodiments, the user may initiate the capture in response to a promptto do so.

8.4.3.2.2 Capture “n” Images 520

When image capture is initiated, the processor 310 via sensor 340captures a number n of images, which is preferably more than one image.For example, the processor 310 via sensor 340 may capture about 5 to 20images, 10 to 20 images, or 10 to 15 images, etc. The quantity of imagescaptured may be time-based. In other words, the number of images thatare captured may be based on the number of images of a predeterminedresolution that can be captured by sensor 340 during a predeterminedtime interval. For example, if the number of images sensor 340 cancapture at the predetermined resolution in 1 second is 40 images and thepredetermined time interval for capture is 1 second, sensor 340 willcapture 40 images for processing with processor 310. The quantity ofimages may be user-defined, determined by server 210 based on artificialintelligence or machine learning of environmental conditions detected,or based on an intended accuracy target. For example, if high accuracyis required then more captured images may be required. Although, it ispreferable to capture multiple images for processing, one image iscontemplated and may be successful for use in obtaining accuratemeasurements. However, more than one image allows average measurementsto be obtained. This may reduce error/inconsistencies and increaseaccuracy. The images may be placed by processor 310 in stored data 354of memory/data storage 350 for post-capture processing.

8.4.3.3 Post-Capture Image Processing Phase 600

Once the images are captured, the images are processed by processor 310to detect or identify facial features/landmarks and measure distancestherebetween. The resultant measurements may be used to recommend anappropriate patient interface size. This processing may alternatively beperformed by server 210 receiving the transmitted captured images and/oron the user's computing device (e.g., smart phone). Processing may alsobe undertaken by a combination of the processor 310 and server 210. Inone example, the recommended patient interface size may be predominantlybased on the user's nose width. In other examples, the recommendedpatient interface size may be based on the user's mouth and/or nosedimensions.

8.4.3.3.1 Read Images and Detect Facial Features 610 & 620

Processor 310, as controlled by the application, retrieves one or morecaptured images from stored data 354. The image is then extracted byprocessor 310 to identify each pixel comprising the two-dimensionalcaptured image. Processor 310 then detects certain pre-designated facialfeatures within the pixel formation. Detection may be performed byprocessor 310 using edge detection, such as Canny, Prewitt, Sobel, orRobert's edge detection, for example. These edge detectiontechniques/algorithms help identify the location of certain facialfeatures within the pixel formation, which correspond to the patient'sactual facial features as presented for image capture. For example, theedge detection techniques can first identify the user's face within theimage and also identify pixel locations within the image correspondingto specific facial features, such as each eye and borders thereof, themouth and corners thereof, left and right alares, sellion, supramenton,glabella and left and right nasolabial sulci, etc. Processor 310 maythen mark, tag or store the particular pixel location(s) of each ofthese facial features. Alternatively, or if such detection by processor310/server 210 is unsuccessful, the pre-designated facial features maybe manually detected and marked, tagged or stored by a human operatorwith viewing access to the captured images through a user interface ofthe processor 310/server 210.

8.4.3.3.2 Measure Distance Between Facial Features 630

Once the pixel coordinates for these facial features are identified, theapplication controls processor 310 to measure the pixel distance betweencertain of the identified features. For example, the distance maygenerally be determined by the number of pixels for each feature and mayinclude scaling. For example, measurements between the left and rightalares may be taken to determine pixel width of the nose and/or betweenthe sellion and supramenton to determine the pixel height of the user'sface. Other examples include pixel distance between each eye, betweenmouth corners, and between left and right nasolabial sulci to obtainadditional measurement data of particular structures like the mouth.Further distances between facial features can be measured.

8.4.3.3.3 Apply Anthropometric Correction Factor 640

Once the pixel measurements of the pre-designated facial features areobtained, an anthropometric correction factor(s) may be applied to themeasurements. It should be understood that this correction factor can beapplied before or after applying a scaling factor, as described below.The anthropometric correction factor can correct for errors that mayoccur in the automated process, which may be observed to occurconsistently from patient to patient. In other words, without thecorrection factor, the automated process, alone, may result inconsistent results from patient to patient, but results that may lead toa certain amount of mis-sized patient interfaces. The correction factor,which may be empirically extracted from population testing, shifts theresults closer to a true measurement helping to reduce or eliminatemis-sizing. This correction factor can be refined or improved inaccuracy over time as measurement and sizing data for each patient iscommunicated from respective computing devices to server 210 where suchdata may be further processed to improve the correction factor. Theanthropometric correction factor may also vary between the forms ofpatient interfaces. For instance, the correction factor for a particularpatient seeking an FFM may be different from the correction factor whenseeking a nasal mask. Such a correction factor may be derived fromtracking of mask purchases, such as by monitoring mask returns anddetermining the size difference between a replacement mask and thereturned mask.

8.4.3.3.4 Measure Reference Feature 650

In order to apply the facial feature measurements to patient interfacesizing, whether corrected or uncorrected by the anthropometriccorrection factor, the measurements may be scaled from pixel units toother values that accurately reflect the distances between the patient'sfacial features as presented for image capture. The reference featuremay be used to obtain a scaling value or values. Thus, processor 310similarly determines the reference feature's dimensions, which caninclude pixel width and/or pixel height (x and y) measurements (e.g.,pixel counts) of the entire reference feature. More detailedmeasurements of the pixel dimensions of the many squares/dots thatcomprise a QR code reference feature 326, and/or pixel area occupied bythe reference feature and its constituent parts may also be determined.Thus, each square or dot of the QR code reference feature 326 may bemeasured in pixel units to determine a scaling factor based on the pixelmeasurement of each dot and then averaged among all the squares or dotsthat are measured, which can increase accuracy of the scaling factor ascompared to a single measurement of the full size of the QR codereference feature 326. However, it should be understood that whatevermeasurements are taken of the reference feature, the measurements may beutilized to scale a pixel measurement of the reference feature to acorresponding known dimension of the reference feature.

8.4.3.3.5 Calculate Scaling Factor 660

Once the measurements of the reference feature are taken by processor310, the scaling factor is calculated by processor 310 as controlled bythe application. The pixel measurements of reference feature are relatedto the known corresponding dimensions of the reference feature, e.g. thereference feature 326 as displayed by display interface 320 for imagecapture, to obtain a conversion or scaling factor. Such a scaling factormay be in the form of length/pixel or area/pixel^2. In other words, theknown dimension(s) may be divided by the corresponding pixelmeasurement(s) (e.g., count(s)).

8.4.3.3.6 Apply Scaling Factor 670

Processor 310 then applies the scaling factor to the facial featuremeasurements (pixel counts) to convert the measurements from pixel unitsto other units to reflect distances between the patient's actual facialfeatures suitable for mask sizing. This may typically involvemultiplying the scaling factor by the pixel counts of the distance(s)for facial features pertinent for mask sizing.

These measurement steps and calculation steps for both the facialfeatures and reference feature are repeated for each captured imageuntil each image in the set has facial feature measurements that arescaled and/or corrected.

8.4.3.3.7 Average Facial Feature Measurements 680

The corrected and scaled measurements for the set of images may thenoptionally be averaged by processor 310 to obtain final measurements ofthe patient's facial anatomy. Such measurements may reflect distancesbetween the patient's facial features.

8.4.3.4 Comparison and Output Phase 700

In the comparison and output phase 700, results from the post-captureimage processing phase 600 may be directly output (displayed) to aperson of interest or compared to data record(s) to obtain an automaticrecommendation for a patient interface size.

8.4.3.4.1 Display Averaged Results 710

Once all of the measurements are determined, the results (e.g.,averages) may be displayed by processor 310 to the user via displayinterface 320. In one embodiment, this may end the automated process.The user/patient can record the measurements for further use by theuser.

8.4.3.4.2 Forward Averaged Results 720

Alternatively, the final measurements may be forwarded eitherautomatically or at the command of the user to server 210 from computingdevice 230 via communication network 220. Server 210 or individuals onthe server-side may conduct further processing and analysis to determinea suitable patient interface and patient interface size.

8.4.3.4.3 Compare Results, Select and Display Recommended Size 730 & 732

In a further embodiment, the final facial feature measurements thatreflect the distances between the patient's actual facial features arecompared by processor 310 to patient interface size data such as in adata record. The data record may be part of the application forautomatic facial feature measurements and patient interface sizing. Thisdata record can include, for example, a lookup table accessible byprocessor 310, which may include patient interface sizes correspondingto a range of facial feature distances/values. Multiple tables may beincluded in the data record, many of which may correspond to aparticular form of patient interface and/or a particular model ofpatient interface offered by the manufacturer.

Processor 310 compares the user's measurements to determine anappropriate size or “best fit,” such as by identifying one or moreranges within which the measurements fall and then selecting theinterface size, such as from a group of standard sizes (e.g., small,medium, or large, etc.), associated with that identified range(s).Processor 310 may then recommend the identified patient interface sizein the form of a display presented on display interface 320. Processor310 may even automatically forward the recommendation via email, textmessage or instant messenger for the user's records. The user mayfurther have the option provided to it via processor 310 to order apatient interface with the recommended size. The order may becommunicated to server 210 where further steps for order fulfilment maytake place.

8.4.4 Alternatives and Additional Application Features

The following describes additional and/or alternative features that maybe implemented with the above described example methods, systems anddevices. The below are not intended to be exhaustive, but are merelyexamples of the many variations that can be achieved while conforming tothe present technology.

8.4.4.1 Alternative Computing Devices

In the above examples, the method is at least in part performed by amobile device as computing device 230. However, the facial featuremeasuring and/or interface sizing can be performed, at least in part,with desktop or laptop 232, for example. In such example, the imagecapture and post-image processing phases 500, 600 would be similar tothat described above. However, the method may differ in the pre-capturephase 400. In this phase, rather than displaying reference feature 326on display interface 320 and positioning display interface 320 anduser's facial features in front of mirror 330 so that reference feature326 is captured in the image, the reference feature can be printed ontoa sheet of paper at a known scale and held by the user. As such, webcam233 could display, via processor 310, a live action preview of the userand the reference feature on the display interface, which may be amonitor. A targeting box, similar to that described above, would also bedisplayed, in which case the user may reposition themselves and thereference feature so that the reference feature or user's face ispositioned within the targeting box.

8.4.4.2 Alternative Reference Features

While example reference feature 326 displayed by display interface 320described above may include a QR code or other processor detectablereference feature, other reference features of known dimensions, eitherdisplayed by display interface 320 or positioned in close proximity tothe user, may be utilized. When the reference feature is not a displayedfeature captured through a mirror 330, the reference feature may be aknown physical feature, suggested by the application, and positionednear the user. For example, a sheet of paper, coin, credit card orcardboard cut-out with a QR code superimposed thereon may be used as areference feature. While such close-positioned reference features couldbe used in the method implementing a mirror 330, such reference featurescould be particularly useful in a desktop computing device methoddescribed directly above. In one example a user may hold up a creditcard of known size (standard) such that the processor may detect thecard as the reference feature for purposes of determining a scalingfactor. In another embodiment, a sheet of paper of known size, such assize A4 paper, can be held in either landscape or portrait orientation.Processor, via sensor 233 may detect corners and/or aspect ratio of thepaper to determine when it is aligned with an alignment box as aprecondition to image capture and/or to determine a scaling factor fromone or more images including the paper reference feature, which is ofknown size. A further implementation in which a coin is used as thereference feature is described in more detail below.

8.4.4.2.1 Coin

FIG. 8 contains a flow chart illustrating a method 800 that may be usedin place of the process 600 to implement the post-capture imageprocessing phase in an implementation in which a coin is used as thereference feature. In such an implementation, there is no need for thepre-capture phase 400. The coin 1300 is placed on the user's forehead1310 approximately above the nose, as illustrated in FIG. 13A, prior tothe image capture phase 500 described above. Under normal skinconditions the coin will adhere to the user's forehead 1310 forsufficient time to complete the image capture phase 500. The method 800is then carried out to implement the post-capture image processingphase, and finally the comparison and output phase 700 is carried out asdescribed above.

The method 800 starts at step 810, which is the first step of a loopover all images captured during the image capture phase. Step 810 readsthe next captured image. Step 820 detects facial features (eyes andmouth) in the captured image. Step 820 will be described in more detailbelow with reference to FIG. 9. Step 830 detects the reference feature(the coin) in the captured image. Step 830 will be described in moredetail below with reference to FIG. 10. Step 840 uses the referencefeature to calculate a scaling factor. Step 840 will be described inmore detail below with reference to FIG. 11. The next step 850 makes ameasurement of the facial features detected in the captured image atstep 820. Step 850 may alternatively be performed before steps 830 and840. Step 850 will be described in more detail below with reference toFIG. 12. Step 860 then multiplies the facial feature measurement made atstep 850 by the scaling factor calculated at step 840. Step 870 checkswhether the end of the captured image set has been reached. If not(“N”), the method 800 returns to step 810 to read the next capturedimage. Otherwise (“Y”), the final step 880 averages the scaled facialfeature measurements for all captured images to produce a final scaledfacial feature measurement ready for the comparison and output phase 700described above.

FIG. 9 contains a flow chart illustrating a method 900 that may be usedto implement the facial feature detection step 820 of the method 800according to one implementation. The method 900 starts at step 902,which detects the faces in the image. The faces within the image may befound, for example, using an OpenCV cascade classifier with thresholdson object size. Each pair of eyes and mouth within each detected face isfound using corresponding cascade classifiers. This result of step 902is a list of rectangles or “boxes” defining the boundary of eachdetected face within the image. For each detected face, a list of boxesdefining the position and extent of the eye(s) and mouth(s) found withinthe face are returned by step 902. Step 902 also returns, for eachdetected face, a box for each coin found within the face. These boxesmay be used by step 830 to detect the correct reference feature withinthe detected face.

The following steps 905 to 960 are carried out for the largest face boxdetected at step 902. Steps 905 to 960 filter the features detectedwithin the face to choose only the “best” matches and remove anyduplicates/incorrect matches.

Step 905 checks whether fewer than two eyes or no mouth was found by theface detection step 902. If so (“Y”), the method 900 ends at step 960.If not (“N”), step 910 checks whether exactly two eyes and one mouthwere found at step 902. If so (“Y”), step 915 stores the two eye boxesand the mouth box, and the method 900 then ends at step 960. If not(“N”), step 920 checks whether two eyes were found at step 902. If so(“Y”), step 925 stores the two eye boxes, and the method 900 proceeds tostep 940 described below. If not (“N”), step 930 checks whether onemouth was found at step 902. If so, step 935 stores the mouth box, andthe method 900 proceeds to step 940. If not (“N”), step 940 checkswhether more than one mouth was found at step 902. If so (“Y”), step 945stores the widest mouth box of the multiple mouth boxes, and the method900 then ends at step 960. Otherwise (“N”), step 950 checks whether nomouth was found at step 902. If so (“Y”), step 955 stores a null mouthbox (with corners (0,0) and (0,0)), and the method 900 then ends at step960. Otherwise (“N”), the method 900 ends at step 960.

In other cascade-classifier implementations of step 820, other criteriamay be used to filter the boxes found within the largest face box atstep 902 to return the most probable eye and mouth boxes.

FIG. 10 contains a flow chart illustrating a method 1000 that may beused to implement the reference feature detection step 830 of the method800 according to the implementation of the method 800 in which themethod 900 is used to implement the step 820. Steps 1010 to 1090 arecarried out on the largest face box detected at step 902 of the method900 to identify the “best” detected coin within the face. Step 1010checks whether no coin was detected within the face at step 902. If so(“Y”), the method 1000 ends at step 1090. Otherwise (“N”), step 1020checks whether exactly one coin was detected at step 902. If so (“Y”),step 1030 stores the coin box, and the method 1000 ends at step 1090.Otherwise (“N”), step 1040 loads a “template image”, i.e. a referenceimage of the reference feature. Steps 1050 to 1070 are then carried outfor each of the multiple coins detected in the face at step 902. Step1050 computes a measure of match between the current coin and thereference image. In one implementation, step 1050 counts the number ofmatching points between the current coin and the reference image. Step1060 then stores the measure of match found at step 1050. Step 1070checks whether all the coins have been matched. If not (“N”), the method1000 returns to step 1050. If so (“Y”), step 1080 finds the largestmeasure of match stored at step 1060, and stores the box of the coinwith the largest match measure. The method 1000 then ends at step 1090.

FIG. 11 contains a flow chart illustrating a method 1100 that may beused to implement the calculating of a scaling factor step 840 of themethod 800 according to one implementation. Steps 1105 to 1175 arecarried out for the “best” coin detected at step 830. The first step1105 converts the image contained within the coin box to separate hue(H) and saturation (S) channels. Step 1110 then computes a histogram foreach of the H and S channels of the box. Then, step 1115 finds the peaksof the H and S channel histograms. Steps 1120 to 1150 are then carriedout for each pair of peaks in the H and S channel histograms. Step 1120thresholds the H and S channel images using thresholds equal to thecurrent respective peak locations. Step 1130 then detects images in thethresholded (binary) H and S images. In one implementation, step 1130uses a Canny edge detection filter on the binary images. Step 1135 thencombines the two edge images using a binary “AND” operation, such thatthe only surviving edge pixels are those that were detected in both Hand S binary images. The next step 1140 fits an ellipse to the combinededge image. Step 1140 may use any convenient method, e.g. linearregression, to fit an ellipse to the combined edge image. An ellipse isfit to the combined edge image at step 1140 because a circle rotatedthree-dimensionally through any angle appears as an ellipse. Step 1145calculates the coefficient of determination (written as R²) of theellipse fitted at step 1140. Step 1150 then removes the ellipse if thecoefficient of determination is too low or the number of edge pixels inthe combined edge image is too low.

After the final pair of H, S histogram peaks has been processed, step1155 selects the ellipse with the highest coefficient of determination.Step 1160 then compares the width (horizontal diameter) and height(vertical diameter) of the selected ellipse. If the width is greaterthan the height (“Y”), step 1165 sets the measured diameter of the cointo the width of the ellipse (as a pixel count). Otherwise (“N”), step1170 sets the measured diameter of the coin to the height of the ellipse(as a pixel count). Finally, step 1175 calculates the scaling factor asthe true diameter of the coin (a known quantity, e.g. in millimetres)divided by the measured diameter of the coin from step 1170 or step1165.

This calculation is based on the fact that when a circular disc isrotated through any angle its projected outline appears as an ellipse,and the length of the major axis of the ellipse is the diameter of thedisc regardless of the amount or direction of rotation. This factunderpins the suitability of circular reference features such as coinsfor calculating scaling factors for image measurements.

FIG. 12 contains a flow chart illustrating a method 1200 that may beused to implement the facial feature measurement step 850 of the method800 according to one implementation in which the facial featuremeasurement is face height. The method 1200 starts at step 1210, whichdraws an eyeline, i.e. a line between the centers of the two eye boxesselected at step 820. The eyeline is illustrated as the line 1360 inFIG. 13B, while the two eye boxes are illustrated as 1330 and 1340. Step1220 determines a midpoint of the eyeline. Step 1230 then draws amidline from the midpoint found at step 1220 in a directionperpendicularly downwards from the eyeline found at step 1210. Themidline drawn at step 1230 is illustrated as 1370 in FIG. 13B. Step 1240then measures the face height as the length of the midline to the pointwhere the midline intersects the bottom of the mouth box selected atstep 820.

The face height measured at step 1240 may differ from the actual faceheight of the user because of a small rotation of the face around ahorizontal axis. The ellipse found at step 840 can supply a correctionfor such a small horizontal rotation. The ratio of the true face height(in pixels) to the measured face height from step 1240 is the same asthe ratio of the true height of the coin (in pixels) to the measuredheight of the ellipse from step 1160, if that height is smaller than themeasured width (indicating horizontal rotation has taken place). Step1250 therefore checks whether the measured height of the ellipse fromstep 1160 is less than the measured width, also from step 1160. If so(“Y”), the measured face height from step 1240 may be corrected forhorizontal rotation at step 1260 by multiplying the measured face heightby the ratio of the true height of the coin (in pixels) to the measuredheight of the ellipse from step 1160. The true height of the coin inpixels is simply the length of the major axis of the ellipse. An exampleof an ellipse for a detected coin is illustrated as 1320 in FIG. 13B. Inthe ellipse 1320, the width is less than the height, so there is no needfor correction of the measured face height for horizontal rotation.

An alternative implementation of the method 800 makes use of an activeshape model (ASM) [1] to detect the facial features at step 820. Ingeneral, an active shape model uses identified landmarks within a set oftraining images to develop a deformable model for the relative positionsof the landmarks (the shape) and a statistical model of the pixel valuesprovided by the images at those positions. The deformable shape model isdefined as:

x=x+Pb  (Eq. 1)

where x is a vector of landmark positions (the shape) as predicted bythe model, x is the mean shape, P is a set of eigenvectors alsodetermined from the training set, and b is a vector of weights (thepose) allowing for the shape to be deformed. The statistical model ofpixel values is determined by sampling a range of pixels normal to eachlandmark within each image in the training set. After sampling, a vectorof mean pixel values is determined for each landmark as well as thecorresponding covariance matrix. The pixel model for each landmarkcomprises the vector of mean pixel values and the correspondingcovariance matrix.

The process of searching for landmarks in a captured image using an ASMis iterative. For the first iteration, the mean shape x is used as theshape estimate x and is superimposed on the captured image in an initiallocation that is presumably not too far from the landmarks in thecaptured image, e.g. centred within the captured image. A range of pixelvalues are sampled at each landmark position in the captured image asdefined by the current shape estimate x. The new estimated landmarkpositions are then selected by determining the range of pixels with thesmallest Mahalanobis distance (covariance-weighted Euclidean distance)from the mean pixel values in the pixel model. The scale, translationand rotation of the shape estimate x are then updated to best match thenew estimated landmark positions. Any residual error that remains isthen used to deform the model by updating the current pose estimate b.The shape estimate x is then updated using Eq. 1. These steps arerepeated until some high proportion (e.g. at least 90%) of the estimatedlandmark positions have converged within a small radius (e.g. 2 pixels)of the previous estimated positions; at this point the changes to shapescale, translation, rotation, and pose are presumed minimal. Theconvergence may be accelerated by repeating the iterative process over athree-level Gaussian pyramid with each level L containing a copy of thecaptured image decimated by 2^(L). Changes to landmark positions atcoarse levels produce larger relative movements, and once shapeconvergence occurs, the iterative process moves up a level, producingfiner changes in shape and pose. FIG. 14 illustrates the landmarkpositions identified by the iterative process in a typical capturedimage 1400.

In the implementation of the method 800 in which the ASM is used toimplement step 820, the reference feature detection step 830 mayinitially use the cascade classifier described above in relation to step902 to detect one or more “coin boxes”, and then use the method 1000described above to select the “best” detected coin.

In the alternative implementation of the method 800, the facial featuremeasurement step 850 measures the pixel distance between two selectedlandmarks that are suitable for sizing the mask. In one exampleillustrated in FIG. 14, suitable for sizing a nasal mask (see FIG. 1B),the selected landmarks are the left and right alar crest points 1410 and1420 (see FIG. 3B), yielding a facial feature measurement of nose width.

8.4.4.2.2 Cornea

In a further implementation, the reference feature may be a feature ofthe eye(s) such as the iris or cornea of the user. Iris diameter isremarkably similar across all races, and does not grow after the earlyteens. The range of corneal diameters (horizontal visible iris diameter)is within 11.0 to 12.5 mm for 95% of adults [2]. The advantage of usingthe eye feature is that it obviates the need for an extraneous referencefeature such as a coin, credit card, QR code etc. to be present in thecaptured image. In such an implementation, method 800 may be implementedas follows. The bounding points of one or each cornea may be detected aspart of an ASM implementation of the facial feature detection step 820,in which the bounding points for each cornea are landmarks in the ASM. Aseparate reference feature detection step 830 would therefore not berequired. Step 840 may compute the diameter of one or each cornea as thedistance between the bounding points of the or each cornea, and computethe scaling factor as the ratio of the median corneal diameter of 11.75mm to the measured corneal diameter (in pixels) for one or other eye, orthe average of both measured corneal diameters. In a variation of step840, the median corneal diameter is chosen based on knowledge of theuser's age, since variation of corneal diameter across people of a givenage is less than variation across the general adult population.

8.4.4.3 Assistant Mode

A mirror 330 is described above as being implemented to assist a user incapturing an image. However, the application for measuring and sizingmay allow for alternatives. For example, processor 310, as controlled bythe application, may provide the user with the option to use mirror 330or a third party to hold sensor 340 and aim it directly at the intendedmask user. Thus, the intended mask user may have his/her facial featuresand the reference feature captured by a relative, a friend, or astationary stand that holds sensor 340. As such, the application mayinclude a “partner” or “assistant” mode in which display interface 320may present a live camera preview and a targeting box, such as cameralive action preview 324 and targeting box 328. The application may theninstruct the assistant on how to capture suitable images for masksizing. For example, in this mode, processor 310 may optionally operateto allow the assistant to select the front facing camera or rear facingcamera, which may be integrated into smartphone 234 or tablet 236. Thus,the assistant may look at display interface 320 and point the rearfacing camera at the patient's facial features and a reference featurethat may be held by the patient. “Partner” or “assistant” mode may alsoprovide the user with the option to operate the front facing camera.Optionally, a stand can be used to hold the mobile device, while theuser moves with respect to camera 340 until a reference feature held bythe user is properly aligned within a target box displayed on displayinterface 320.

8.4.4.4 Lighting and Light Filters

It is also described above that if lighting conditions areunsatisfactory, processor 310, as controlled by the application, maynotify the user that conditions are unsatisfactory and provideinstructions for moving to a location of brighter or dimmer lighting.However, recognizing that satisfying this condition may not always bepossible, the application may control the processor 310 to apply a lightfilter to the sensor/camera 340 to allow for operation in a wide arrayof lighting conditions. If the environment is too bright, a specificfilter may be automatically applied so that the user's facial featurescan be easily detected. Conversely, where lighting conditions are toodark, another filter may be implemented to detect the desired facialfeatures or the computing device's light source to illuminate thepatient's facial features. This may be performed during the pre-capturephase 400.

8.4.4.5 Alternative Sensors

The method described herein is particularly useful for measuring andsizing based on two-dimensional images as cameras for two-dimensionalimages are ubiquitous. However, the disclosed technology contemplatesother types of sensors that may be able to determine scale without theuse of a reference feature, such as a laser and detector combination.For example, such a sensor may detect distance to the target, which canbe used to calculate a scale. Other sensors may be utilized to obtainthree-dimensional renderings. For example, a stereoscopic camera may beused to obtain a three-dimensional image. A similar process to thatdescribed above can be performed on the three-dimensional image. In suchan embodiment, the reference feature can be a three dimensional objectwith known x, y, and z dimensions. Further sensors that can be used area strobing light source and detector combination. Reflected light fromthe strobing light source can be timed to calculate distance in theprocessor.

8.4.4.6 Storage Mediums for the Application

In the exemplary method detailed above, the application for automaticfacial feature measuring and patient interface sizing is downloaded tothe computing device's internal memory from a third party server, suchas an application-store server. However, in one embodiment, theapplication may be downloaded to the computing device's internalmemory/data storage 350 via the network from server 210 or via someother external computer-readable storage medium, such as a flash drive,SD card or optical disc. Alternatively, in another embodiment, theapplication may be stored in an external computer-readable storagemedium and directly linked to processor 310. In a further embodiment,the application including its corresponding processor instructions anddata, may be stored on a medium external to computing device 230, suchas server 210, and accessed by computing device 230 via a web browser(e.g., Google Chrome® or Internet Explorer®) and/or web browserextension such as Adobe Flash®.

8.4.4.7 Tracking & Updates

The application may include additional functionality such as trackingthe user's weight over time and corresponding facial changes as theuser's weight fluctuates, which may be integrated into the patientinterface recommendation analysis. For example, weight, age and/orheight may be a parameter that is considered in the data record forselection of the appropriate mask size. Additionally, the applicationmay record the particular patient interfaces that the user/patientorders and the date that the order occurred so that replacement and/ormaintenance reminders can be provided to the user via the applicationand/or for general health monitoring.

In addition, the application can be updated from time to time, which canbe provided to users via an application store or server 210. Theseupdates can provide users with new reference features and the knowndimension information for the reference feature, updated mask sizingtables and new mask type information, and other data processinginformation, such as updated anthropometric correction factors, whichcan be can be continuously refined as more and more end users use theapplication and send their information back through server 210.Advantageously, the ability to update the reference feature remotely canenable more accurate measurements to be obtained or improveresponsiveness of the application when subsequent reference features aredeveloped. Remote updating may be a seamless background process thatrequires little or no user interaction, for example, the updatingoccurring when the application is loaded and an update is available.Remote updating of the application means that the subsequent versions ofthe application can also take advantage of more powerful, better oradditional hardware components that are provided with newer models ofcomputing device 230.

8.4.4.8 Other Image Sources

In an exemplary method described above, the images are captured by asensor 340 such as a camera that is located on the same computing device230 as the processor 310 that carries out the application 360 for facialfeature measuring and patient interface sizing. However, in otherimplementations, the processor 310 may receive the images from anothersource over the network 220 to which the computing device 230 isconnected. Examples of other sources include an MMS message, email, aweb or other image server, e.g. the server 210. In still otherimplementations in which the server 210 carries out the application 360for facial feature measuring and patient interface sizing, the server210 may receive the images from another source over the network 220 towhich the server 210 is connected.

8.5 Other Remarks

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in Patent Office patent files orrecords, but otherwise reserves all copyright rights whatsoever.

Unless the context clearly dictates otherwise and where a range ofvalues is provided, it is understood that each intervening value, to thetenth of the unit of the lower limit, between the upper and lower limitof that range, and any other stated or intervening value in that statedrange is encompassed within the technology. The upper and lower limitsof these intervening ranges, which may be independently included in theintervening ranges, are also encompassed within the technology, subjectto any specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the technology.

Furthermore, where a value or values are stated herein as beingimplemented as part of the technology, it is understood that such valuesmay be approximated, unless otherwise stated, and such values may beutilized to any suitable significant digit to the extent that apractical technical implementation may permit or require it.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this technology belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present technology, a limitednumber of the exemplary methods and materials are described herein.

When a particular material is identified as being used to construct acomponent, obvious alternative materials with similar properties may beused as a substitute. Furthermore, unless specified to the contrary, anyand all components herein described are understood to be capable ofbeing manufactured and, as such, may be manufactured together orseparately.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include their plural equivalents,unless the context clearly dictates otherwise.

As used herein, the terms “about,” “generally” and “substantially” areintended to mean that deviations from absolute are included within thescope of the term so modified.

All publications mentioned herein are incorporated herein by referencein their entirety to disclose and describe the methods and/or materialswhich are the subject of those publications. The publications discussedherein are provided solely for their disclosure prior to the filing dateof the present application. Nothing herein is to be construed as anadmission that the present technology is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dates,which may need to be independently confirmed.

The terms “comprises” and “comprising” should be interpreted asreferring to elements, components, or steps in a non-exclusive manner,indicating that the referenced elements, components, or steps may bepresent, or utilized, or combined with other elements, components, orsteps that are not expressly referenced.

The subject headings used in the detailed description are included onlyfor the ease of reference of the reader and should not be used to limitthe subject matter found throughout the disclosure or the claims. Thesubject headings should not be used in construing the scope of theclaims or the claim limitations.

Although the technology herein has been described with reference toparticular examples, it is to be understood that these examples aremerely illustrative of the principles and applications of thetechnology. In some instances, the terminology and symbols may implyspecific details that are not required to practice the technology. Forexample, although the terms “first” and “second” may be used, unlessotherwise specified, they are not intended to indicate any order but maybe utilised to distinguish between distinct elements. Furthermore,although process steps in the methodologies may be described orillustrated in an order, such an ordering is not required. Those skilledin the art will recognize that such ordering may be modified and/oraspects thereof may be conducted concurrently or even synchronously.

It is therefore to be understood that numerous modifications may be madeto the illustrative examples and that other arrangements may be devisedwithout departing from the spirit and scope of the technology.

8.6 Reference Label List

-   patient 10-   bed partner 20-   capture 40-   air circuit 50-   humidifier 60-   patient interface 100-   plenum chamber 120-   structure 130-   vent 140-   forehead support 150-   seal-forming structure 160-   connection port 170-   system 200-   server 210-   network 220-   network 222-   wireless network 224-   wireless link 226-   computing device 230-   laptop 232-   webcam 233-   smartphone 234-   tablet 236-   architecture 300-   processor 310-   display interface 320-   display 320 a-   detection points 321-   capture display 322-   bounding boxes 323-   live action preview 324-   reference feature 326-   status indicators 327-   targeting box 328-   reference feature image 329-   mirror 330-   user control/input interface 331-   sensor 340-   IMU 342-   memory/data storage 350-   instructions 352-   stored data 354-   application 360-   pre-capture phase 400-   step 410-   step 420-   step 430-   step 440-   step 450-   image capture phase 500-   step 510-   step 520-   post-image processing phase 600-   step 610-   step 620-   step 630-   step 640-   step 650-   step 660-   step 670-   step 680-   output phase 700-   step 710-   step 720-   step 730-   step 732-   method 800-   step 810-   step 820-   step 830-   step 840-   step 850-   step 860-   step 870-   step 880-   method 900-   step 902-   step 905-   step 910-   step 915-   step 920-   step 925-   step 930-   step 935-   step 940-   step 945-   step 950-   step 955-   step 960-   method 1000-   step 1010-   step 1020-   step 1030-   step 1040-   step 1050-   step 1060-   step 1070-   step 1080-   step 1090-   method 1100-   step 1105-   step 1110-   step 1115-   step 1120-   step 1130-   step 1135-   step 1140-   step 1145-   step 1150-   step 1155-   step 1160-   step 1165-   step 1170-   step 1175-   method 1200-   step 1210-   step 1220-   step 1230-   step 1240-   step 1250-   step 1260-   coin 1300-   forehead 1310-   ellipse 1320-   line 1360-   captured image 1400-   right alar crest point 1410-   right alar crest point 1420

8.7 Cited References

[1] Cootes, T. F., Taylor, C. J., Cooper, D. H., & Graham, J. (1995).Active Shape Models—Their Training and Application. Computer Vision andImage Understanding, 61(1), 38-59.[2] Florian Rufer, MD, Anke Schroder, MD, and Carl Erb, MD.White-to-White Corneal Diameter: Normal Values in Healthy HumansObtained With the Orbscan II Topography System. Cornea, 24(3), 259-261,April 2005.

1. A non-transitory computer-readable medium containing processorcontrol instructions, which when executed by one or more processors,control operations for an automated method for selecting a patientinterface according to patient interface size, the processor controlinstructions comprising: instructions to control displaying apredetermined reference feature having a known dimension on a displayinterface of a display device; instructions to receive image datacaptured by an image sensor coupled with the display device, thecaptured image data containing one or more facial features of anintended user of the patient interface in association with a displayedversion of the predetermined reference feature being displayed on thedisplay interface of the display device; instructions to detect one ormore facial features of the user in the captured image data;instructions to detect the displayed version of the predeterminedreference feature in the captured image data; and instructions toprocess image pixel data of the image to measure an aspect of the one ormore facial features detected in the image based on the displayedversion of the predetermined reference feature.
 2. The non-transitorycomputer-readable medium of claim 1 wherein the processor controlinstructions further comprise instructions to select a patient interfacesize from a group of standard patient interface sizes based on acomparison between the measured aspect of the one or more facialfeatures and a data record relating sizing information of the group ofstandard patient interface sizes and the measured aspect of the one ormore facial features.
 3. The non-transitory computer-readable medium ofclaim 1 wherein the aspect of the one or more facial features comprisesa distance between a sellion and supramenton of the user.
 4. Thenon-transitory computer-readable medium of claim 1 wherein theinstructions to process image pixel data comprise processinginstructions to calculate a value of the measured aspect based on ascaling factor derived from the image pixel data associated with thedisplayed version of the predetermined reference feature.
 5. Thenon-transitory computer-readable medium of claim 1 wherein theinstructions to process image pixel data further comprise processinginstructions to adjust a value of the measured aspect with ananthropometric correction factor.
 6. The non-transitorycomputer-readable medium of claim 5 wherein the anthropometriccorrection factor is based on patient interface return data.
 7. Thenon-transitory computer-readable medium of claim 1, wherein the displayinterface includes a targeting guide and a live action preview ofcontent detected by the image sensor, the content including thedisplayed version of the predetermined reference feature being displayedon the display interface of the display device.
 8. The non-transitorycomputer-readable medium of claim 7, wherein the processor controlinstructions comprise instructions to control capturing of the imagedata to satisfy at least one alignment condition.
 9. The non-transitorycomputer-readable medium of claim 8, wherein the at least one alignmentcondition comprises detection of positioning of the displayed version ofthe predetermined reference feature of the live action preview within abox of the targeting guide.
 10. The non-transitory computer-readablemedium of claim 9, wherein the at least one alignment condition includesdetection of a tilt condition being within about +/−10 degrees of asuperior-inferior extending axis.
 11. The non-transitorycomputer-readable medium of claim 10, wherein the at least one alignmentcondition includes detection of a tilt condition being within about +/−5degrees of a superior-inferior extending axis.
 12. The non-transitorycomputer-readable medium of claim 11, wherein detection of a tiltcondition is performed by reading an inertial measurement unit (IMU).13. The non-transitory computer-readable medium of claim 1 wherein thepatient interface comprises a mask or nasal mask.
 14. The non-transitorycomputer-readable medium of claim 1 wherein the instructions to processimage pixel data comprise instructions to count pixels.
 15. Thenon-transitory computer-readable medium of claim 2 wherein the processorcontrol instructions further comprise instructions to control generatingan automated electronic offer for a patient interface for purchase basedon the selected patient interface size.
 16. The non-transitorycomputer-readable medium of claim 1, wherein the processor controlinstructions further comprise instructions to calculate an average ofthe measured aspect of the facial feature from a plurality of capturedimages of the one or more facial features.
 17. A system forautomatically recommending a patient interface size complementary to aparticular patient's facial features comprising: one or more processorsconfigured to: display a predetermined reference feature having a knowndimension on a display interface of a display device; receive capturedimage data of an image, the captured image data containing one or morefacial features of a user in association with a displayed version of thepredetermined reference feature being displayed on the display interfaceof the display device, the image data captured with an image sensor thatis coupled with the display device; detect one or more facial featuresof the user in the captured image data; detect the displayed version ofthe predetermined reference feature in the captured image data; andprocess image pixel data of the image to measure an aspect of the one ormore facial features detected in the image based on the displayedversion of the predetermined reference feature.
 18. The system of claim17 wherein the one or more processors are further configured to select apatient interface size from a group of standard patient interface sizesbased on a comparison between the measured aspect of the one or morefacial features and a data record relating sizing information of thegroup of standard patient interface sizes and the measured aspect of theone or more facial features.
 19. The system of claim 18 wherein thepatient interface comprises a mask or nasal mask.
 20. The system ofclaim 17 wherein the one or more processor comprises a mobile computingdevice, the mobile computing device configured to communicate with oneor more servers over a network.
 21. The system of claim 17 wherein theone or more processors comprises one or more servers.
 22. The system ofclaim 21 wherein the one or more servers is configured to transfer bydownload to a computing device comprising a mobile device processor ofthe one or more processors, via a network, processor controlinstructions for operating the mobile device processor for automaticallyrecommending a patient interface size complementary to a particularpatient's facial features.
 23. Apparatus for automatically recommendinga patient interface size complementary to a particular patient's facialfeatures, the apparatus comprising: means for displaying a predeterminedreference feature having a known dimension; means for receiving imagedata captured by an image sensor, the captured image data containing oneor more facial features of an intended user of the patient interface inassociation with a displayed version of the predetermined referencefeature being displayed on the means for displaying; means for detectingone or more facial features of the user in the captured image data;means for detecting the displayed version of the predetermined referencefeature in the captured image data; and means for processing image pixeldata of the image to measure an aspect of the one or more facialfeatures detected in the image based on the displayed version of thepredetermined reference feature.
 24. The apparatus of claim 23 furthercomprising: means for selecting a patient interface size from a group ofstandard patient interface sizes based on a comparison between themeasured aspect of the one or more facial features and a data recordrelating sizing information of the group of standard patient interfacesizes and the measured aspect of the one or more facial features.